By Alan Hoffman on October 7, 2016

pill bottleAt the heart of the concept of defective product design embodied in the Restatement (Third) of Torts: Product Liability is the availability of a reasonable alternative design which could have reduced or avoided a risk of harm. However, a product may be defective, even if no reasonable alternative design exists, if it fails to provide reasonable instructions or warnings of a foreseeable risk of harm. A recent decision of the Massachusetts Appeals Court illustrates the application of these principles.

In Niedner v. Ortho-McNeil Pharmaceutical, Inc., N.E.3d, 2016 WL 5106479 (Mass. Appeals, September 21, 2016) 17-year old Adrianna Duffy died of a pulmonary embolism three months after she began using Johnson & Johnson’s Ortho Evra contraceptive patch. Her mother sued Ortho and J & J alleging that the patch caused Duffy’s death and that its design was defective and unreasonably dangerous, and that the defendants failed to adequately warn of its increased risk of blood clotting as against oral contraceptives. The court granted summary judgment for the defendants, and plaintiff appealed.

The plaintiff contended that the patch was defective and unreasonably dangerous and that oral contraceptives were a reasonable and feasible alternative, asserting that the patch “delivers a variable and unreasonably dangerous amount of estrogen, up to 56 micrograms, directly to the bloodstream, unlike any contraceptive on the market and, as a result, it is twice as likely to cause a fatal blood clot.” The Appeals Court stated that while both products are hormonal contraceptives, “the difference in the drug delivery method, each of which has its own advantages and disadvantages, makes the pill fundamentally different from the patch.” “As such,” it held, “one cannot serve as a safer alternative for the other,” citing illustration 9 to the Third Restatement, Section 2.

The design defect holding in Niedner highlights an important point: a different product cannot serve as a reasonable alternative to the product at issue. The cited illustration is a claim that a small car is defective and unreasonably dangerous because a larger vehicle could be more crashworthy and less likely to injure occupants in an accident. The larger vehicle is not a safer alternative design, however, because the small car has benefits such as lower cost, better fuel economy, ease of parking, etc. which the larger vehicle lacks. In Niedner, the plaintiff’s burden was to show that a lower estrogen quantity patch or a patch otherwise having less risk of fatal clotting, could feasibly have produced. Absent such proof, her design defect claim failed.

Design defect claims such as that asserted in Niedner are sometimes characterized as “category liability,” in that they would make a manufacturer liable for selling a lawful product with known risks that cannot be reduced without changing the fundamental characteristics of the product. In effect, category liability allows juries to decide that certain types of products are so inherently dangerous that their sale should be outlawed. Comment d to section 2 of the Third Restatement says, “courts generally have concluded that legislatures and administrative agencies can, more appropriately than courts, consider the desirability of commercial distribution of some categories of widely used and consumed, but nevertheless dangerous, products.”

Such products may still be defective because of inadequate instructions or warnings. Niedner’s warning claim was based on failure to warn of the alleged excessive level of estrogen and increased risk of a fatal blood clot, relying on MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 475 N.E.2d 65 (1985).  In MacDonald the plaintiff claimed that an oral contraceptive caused a stroke, and the Court upheld a jury determination that the warning was insufficient because it included the possibility of fatal blood clots that could lodge in the lungs or the brain, but did not expressly mention stroke. By contrast, in Niedner the Appeals Court found that the package insert was “abundant in its warning of possibility of blood clots in the lung that could lead to death,” including a study that showed a doubling of the risk of serious blood clots as compared to oral contraceptives, and held that the warnings were “plain, numerous and comprehensive” as a matter of law.

While the Third Restatement’s requirement of a reasonable alternative design is widely followed, some states reject it. In this as in other respects, where a product seller is sued can make a significant difference in its liability exposure.